[Asia Economy Reporter Oh Ju-yeon] CrystalGenomics announced on the 19th that it has submitted an application to the Ministry of Food and Drug Safety for orphan drug designation of 'Ivaltinostat' for pancreatic cancer indication.
The application for orphan drug designation as a first-line treatment for pancreatic cancer was submitted based on the newly enacted Advanced Regenerative Medicine and Advanced Biopharmaceutical Safety and Support Act (ARMA), along with all relevant data. In the past, conditional new drug approval and orphan drug designation were reviewed separately, but under the newly implemented expedited review system at the end of last September, both will be reviewed together, which is expected to significantly shorten the review period.
Previously, in June 2018, Ivaltinostat was designated as a 'development-stage orphan drug' by the Ministry of Food and Drug Safety for the pancreatic cancer indication.
According to the phase 2 clinical trial data of Ivaltinostat for pancreatic cancer presented at the European Society for Medical Oncology Gastrointestinal Cancers Symposium (ESMO-WGI) last July, when calculated only for patients who completed the primary endpoint of the clinical trial, which is a 6-cycle (approximately 6 months) or longer treatment regimen, the overall survival (OS) was 12.6 months (vs. 8.5 months for the commonly prescribed first-line treatment gemcitabine + Abraxane combination therapy), demonstrating clinical efficacy.
A CrystalGenomics representative stated, "We expect that Ivaltinostat will have great potential as a new treatment option for patients with unresectable locally advanced or metastatic pancreatic cancer, and we are preparing global clinical trials centered in the United States."
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